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Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 3

Conditions

Chronic Hepatitis B

Treatments

Drug: Tenofovir
Drug: Entecavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01063036
AI463-203
2009-015705-40 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

Enrollment

144 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive
  • Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen
  • Prior entecavir and/or tenofovir monotherapy is allowed
  • Subjects must have compensated liver function

Exclusion criteria

  • Women who are pregnant or breastfeeding
  • Evidence of decompensated cirrhosis
  • Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
  • Moderate or severe renal impairment
  • Recent history of pancreatitis
  • Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study
  • Prior entecavir/tenofovir combination therapy

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

144 participants in 1 patient group

Entecavir + Tenofovir
Experimental group
Treatment:
Drug: Entecavir
Drug: Tenofovir

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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